Point of Care Testing Market: Current Scenario and Forecast (2019-2025): Emphasis on Product (Blood Glucose Monitoring Test, Pregnancy & Fertility Testing, Infectious Disease Testing, Cardiac Markers, Anticoagulant Management, Others), Prescription (Near the Patient Testing (NPT), Over the Counter (OCT) /Patient Self-Testing (PST)), End-User (Hospitals, Clinics & Laboratory, Home Setting, Other Health Facilities) and Regions/countries
December 2019
298
About the Report
About the Report
Diagnostics have evolved with an understanding of biological systems and disease, along with advances in science and technology. Emerging today are entirely new categories of diagnostics, based on the full continuum of care and personalized medicine approaches. With the potential to fundamentally alter clinical practice, these technologies are intended to match the right patient with the right treatment at the right time. As such products mature, clinicians and patients will be better able to assess the risks and benefits of care options and customized health management strategies to optimize individual health and quality of life.
With emerging technological innovations in healthcare, including smartphone apps, biosensors, lab-on-a-chip, and wearable devices-all of which offer a closer connection to the patient point-of-care (POC) technologies are quickly becoming part of the transformation of the healthcare landscape. The driving concept in support of Point-of-Care Testing (POCT) is to bring testing closer to the patient and results conveniently and quickly to the provider to expedite diagnosis and subsequent treatment. POCT offers more flexibility to meet a diverse range of medical needs because small, portable POCT devices make testing possible in a variety of remote locations, such as underserved populations, rural areas, and locations with limited infrastructure or personnel such as disaster, accident, or military sites. Moreover, POCT decreases therapeutic turnaround time (TTAT), increases clinical efficiency, and improves medical and economic outcomes. From consumer-friendly at-home pregnancy and glucose monitoring tests to more complex automated laboratory-based systems, these tests are often first-line health decision tools
Considering the increasing reliance on diagnostics in all phases of patient care, they afford substantial opportunities to improve quality and efficiency. Despite the value and potential of diagnostics, certain internal and external constraints, including regulatory, reimbursement, market, scientific/technical and societal issues, can inhibit the development, adoption and appropriate use of diagnostic products. Rising demand for Point-of-Care (POC) is expected to fuel the market growth further. In addition, the introduction of advanced technologies, such as biochips and nano-biotechnology, and miniaturization of microfluidics are expected to increase the demand for POCT. These advancements have enabled easy access to PoC tests and are likely to facilitate quick and effective test results, thereby boosting the overall market growth.
Based on the application, the POCT industry is bifurcated into glucose monitoring products, pregnancy & fertility testing products, infectious disease testing, cardiac markers, coagulation testing products, and others. Glucose monitoring products segment contributed USD 15,334.6 Million by revenue and is expected to grow with the highest CAGR of 5.10% over the forecast period through 2025. Another segment of this market is end-user, POCT industry is bifurcated into hospitals, clinics & laboratories, home settings, and others on the basis of end-user. The Home Setting segment contributed USD 3,726.5 Million by revenue and is expected to grow with the highest CAGR of 6.09% over the forecast period through 2025. North America dominated the POCT market with a revenue of USD 9,544.3 Million in 2018 and is expected to continue its dominance whereas APAC is the fastest-growing region.
The key sub-segments of Roche as serum work area [SWA], specialty testing, Point-of-Care- all are contributing to the growth of Roche's IVD market. Roche will continue to hold on firmly to the top position in the POCT market. Following the acquisition of Alere, Abbott is set to become the second largest IVD company. Some of the key players operating in the Point-of-Care Testing market include Abbott Laboratories, Becton, Dickinson and Company, Biomerieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, Johnson & Johnson, Roche, Siemens Healthineers, Sysmex Corporation, and Thermo Fisher Scientific are among others. These players are working endlessly to offer consumer a better and affordable healthcare service across the globe.
The preceding figure gives the forecast value of the global Point-of-Care Market from 2019 to 2025. The Global Point-of-Care market would generate a revenue of USD 20,418.9 Million in 2018 and is expected to witness a CAGR growth of 5.33% during the analyzed period 2019-2025, to reach a market size of USD 29,270.7 Million by 2025.
Products
Companies
Abbott Laboratories, Becton, Dickinson and Company, Biomerieux SA, Bio-Rad Laboratories, Inc, Danaher Corporation, Johnson & Johnson, Roche Holding AG, Siemens Healthineers AG, Thermo Fisher Scientific, Sysmex Corporation
Table of Contents
Table of Contents
1. MARKET INTRODUCTION
1.1 Market Definition 20
1.2 Objective of the Study 20
1.3 Limitation 21
1.4 Stakeholders 21
1.5 Currency used in the Report 21
1.6 Scope of the Global Point-of-Care Testing Market Study 22
2. RESEARCH METHODOLOGY 23
2.1 Research Methodology for Global Point-of-Care Testing Market Study 23
2.1.1 Main objective of the Global Point-of-Care Testing Market Study 24
3. COMPREHENSIVE ASSESSMENT OF THE VALUE OF DIAGNOSTIC TESTS 25
3.1 General Overview 25
3.2 Capturing the full spectrum of the value that a diagnostic test contributes 29
3.3 Ensuring the Robust Analyses Underpin the Value Assessment 31
3.4 Accounting for variation in diagnostic test types in value assessment methods 32
3.5 Aligning on how to Define and Measure Value Drivered 34
3.5.1 Value Driver: Clinical Impact 34
3.5.2 Value Driver: Non-Clinical Patient Impact 36
3.5.3 Value Driver: Care Delivery Revenue and Cost Impact 37
3.5.4 Value Driver: Public/Population Impact 39
4. REFRAMING THE DIAGNOSTICS INDUSTRY 40
4.1 General Overview 40
5. COSTS AND BENEFITS OF DIAGNOSTIC TESTING 43
5.1 General Overview 43
5.2 Introduction and problem statement 43
5.2.1 Increasing healthcare costs 43
5.2.2 Underutilization of IVDs in clinical practice 43
5.3 Consequences for patient care 44
5.3.1 Conceptual interventions 45
5.3.1.1 Fostering prevention, screening, early diagnosis, and therapy 45
5.3.1.2 Promoting comprehensive disease management 46
5.3.1.3 Promoting Stratified Disease Management 47
5.3.1.4 Targeted delivery of treatment alongside companion diagnostics 48
5.4 Consequences for policies: promoting a fee for outcomes 50
5.5 Analysis of the Study 51
5.6 Conclusion 53
6. REGULATIONS & GUIDELINES OF POINT-OF-CARE TESTING 54
6.1 General Overview 54
6.2 The United States Point-Of-Care Testing Guidelines 55
6.2.1 Regulations 55
6.2.1.1 CLIA Waived Status for POCT 56
6.2.2 Guidelines 56
6.2.2.1 Obtain Authority to Coordinate Point-of-Care Testing Program 56
6.2.2.2 Select Members of Point-of-Care Committee (POCC) 56
6.2.2.3 Committee Develops a Point-of-Care-Program 57
6.2.2.4 Committee Reviews All Sites for Point-of-Care Testing 58
6.2.2.5 Evaluation of Proposed Testing 58
6.2.2.6 Implementation 60
6.2.2.7 Evaluation of Point-of-Care Testing Program 61
6.3 Canada Point-of-Care Testing Guidelines 61
6.4 Australia Point-of-Care Testing Guidelines 62
6.5 Dubai Point-of-Care Testing Guidelines by Health Regulation Department 63
6.5.1 Introduction 63
6.5.2 Professional Requirement 64
6.5.3 POCT Equipment 65
6.5.4 Documentation and Transmission of Results 66
6.5.5 Quality Control 66
7. RISK MITIGATION 67
7.1 General Overview 67
7.2 Supply Chain 68
7.3 Risk Assessment 69
7.4 Bulk, Custom and Contract Manufacturing 70
8. INDUSTRY PERFORMANCE 71
9. EXECUTIVE SUMMARY 72
10. MARKET OVERVIEW 74
10.1 Introduction of In-Vitro Diagnostics Market 74
10.1.1 Comparison of IVD & POCT 75
10.1.2 Main Categories of Diagnostics 77
10.1.3 Settings of Use 79
10.2 The key to accountable adoption of POCT 81
10.2.1 Drivers of diagnostic technology innovation and adoption: 82
10.2.2 Current challenges for diagnostic innovation 82
10.2.2.1 Regulation 82
10.2.2.2 Evidence generation 83
10.2.2.3 Clinical needs 83
10.2.2.4 Commissioning 83
10.2.2.5 Adoption 83
10.2.3 Current needs 83
10.2.3.1 Three key questions for diagnostic innovation: 83
10.2.4 Developing an evidence 'toolkit' for diagnostic test research 85
10.3 Value of Diagnostics to Health Care and Health Status 87
10.4 Current and Future Use of Diagnostic Products 88
10.4.1 Primary Uses of Diagnostics 88
10.4.1.1 Predictive Applications/Screening/Early Disease Detection 89
10.4.1.2 Diagnostics 89
10.4.1.3 Secondary Risk Assessment; Prognostic 89
10.4.1.4 Drug Selection/Treatment Targeting 89
10.4.1.5 Disease/Condition Monitoring and Management 90
10.4.2 In Vitro Diagnostics: Overview of Future Trends and Directions 90
10.4.2.1 Predict Disease Before Symptoms Appear 90
10.4.2.2 Predict Beneficial and Adverse Treatment Effects 91
10.4.2.3 Enable Personalized Real-Time Treatment and Disease Management Regimens 92
10.4.2.4 Facilitate Point-of-care and Near-patient Testing 93
10.4.2.5 Enable Home Testing 93
10.4.2.6 Public Health, Environmental, Bioterrorism Applications 94
10.4.2.7 Technology and Testing System Integration 95
10.4.3 The importance of Diagnostics in Healthcare 97
10.4.3.1 The role of diagnostics 97
10.4.3.2 Improving patient care 97
10.4.3.3 Reducing healthcare spending 98
10.4.3.4 Reasons In Vitro Diagnostics Are Superior 98
10.5 Market Dynamics 99
10.5.1 Market Drivers 99
10.5.1.1 Increasing Prevalence of Chronic Diseases 99
10.5.1.1.1 The Challenges of Chronic Disease 101
10.5.1.1.2 The Cost of Chronic Diseases 101
10.5.1.2 Rising Geriatric (Elderly) Population 103
10.5.1.3 Technology Advancement 104
10.5.2 Market Restraints 106
10.5.2.1 Stringent Government Regulations for the Manufacturing of POCT Products 106
10.5.2.2 Unfavourable Reimbursement Policies for POCT 107
10.5.2.3 Risk of errors 108
10.5.3 Market Opportunities 109
10.5.3.1 Development of Condition-Specific Markers and Tests 109
10.5.3.2 The growing significance of Companion Diagnostics 110
10.5.4 Market Trends 112
10.5.4.1 Changing Reimbursement Models and Regulations 112
10.5.4.2 Rising Investments in Unifying Technology 114
10.5.4.3 Consolidation and Automation of Labs 114
10.5.4.4 Shift towards Data-Driven Healthcare 115
11. KEY MARKET INDICATORS 116
11.1 Demand 116
11.2 Supply Side Analysis 118
11.2.1 Supply Chain Barriers 120
11.2.1.1 Product Launch 121
11.2.1.2 Partnership 126
11.2.1.3 Business Expansion & Investment 128
11.2.1.4 Mergers and Acquisitions 129
11.2.2 Value Chain Analysis of POC Testing 131
12. MARKET INSIGHT BY PRODUCT 132
12.1 General Overview 132
12.1.1 Blood Glucose Monitoring Test 133
12.1.2 Pregnancy & Fertility Testing 135
12.1.3 Infectious Disease Testing 136
12.1.4 Cardiac Markers 138
12.1.5 Anticoagulant Management 139
12.1.6 Others 140
13. MARKET INSIGHT BY PRESCRIPTION 142
13.1 General Overview 142
13.1.1 Near the Patient Testing (NPT) 143
13.1.2 Over the Counter (OCT) /Patient Self-Testing (PST) 144
14. MARKET INSIGHT BY END USER 145
14.1 General Overview 145
14.1.1 Hospitals 147
14.1.2 Clinics & Laboratory 149
14.1.3 Home Setting 152
14.1.4 Other Health Facilities 155
15. MARKET INSIGHT BY REGION 157
15.1 General Overview 157
15.2 North America POCT Market Insight 160
15.2.1 North America Point-of-Care Testing Market, By Product 161
15.2.2 North America Point-of-Care Testing Market by Prescription 161
15.2.3 North America Point-of-Care Testing Market by End-User 162
15.2.4 North America POCT Market by Country 162
15.2.4.1 United States 163
15.2.4.1.1 Key Findings on Healthcare Spending in the US, 2017 163
15.2.4.1.2 US Health Spending by Type of Service or Product, 2017 164
15.2.4.1.3 Health Spending by Major Sources of Funds 165
15.2.4.1.4 United States Point-of-Care Testing Market, By Product 166
15.2.4.1.5 United States Point-of-Care Testing Market by Prescription 166
15.2.4.1.6 United States Point-of-Care Testing Market by End-User 167
15.2.4.2 Canada 167
15.2.4.2.1 Key Findings on Canada Healthcare Spending, 2018 168
15.2.4.2.2 Key Findings on Hospital sector Spending in Canada, 2017 169
15.2.4.2.3 Canada Point-of-Care Testing Market, By Product 170
15.2.4.2.4 Canada Point-of-Care Testing Market by Prescription 171
15.2.4.2.5 Canada Point-of-Care Testing Market by End-User 171
15.2.4.3 Rest of North America 172
15.2.4.3.1 Rest of North America Point-of-Care Testing Market, By Product 173
15.2.4.3.2 Rest of North America Point-of-Care Testing Market by Prescription 174
15.2.4.3.3 Rest of North America Point-of-Care Testing Market by End-User 174
15.3 Europe POCT Market Insight 175
15.3.1 Europe Point-of-Care Testing Market, By Product 176
15.3.2 Europe Point-of-Care Testing Market by Prescription 176
15.3.3 Europe Point-of-Care Testing Market by End-User 177
15.3.4 Europe POCT Market by Country 177
15.3.4.1 Germany 178
15.3.4.1.1 Germany Point-of-Care Testing Market, By Product 179
15.3.4.1.2 Germany Point-of-Care Testing Market by Prescription 180
15.3.4.1.3 Germany Point-of-Care Testing Market by End-User 180
15.3.4.2 France 181
15.3.4.2.1 France Point-of-Care Testing Market, By Product 182
15.3.4.2.2 France Point-of-Care Testing Market by Prescription 182
15.3.4.2.3 France Point-of-Care Testing Market by End-User 183
15.3.4.3 Spain 183
15.3.4.3.1 Facts on Healthcare Sector Spain 184
15.3.4.3.2 Spain Point-of-Care Testing Market, By Product 185
15.3.4.3.3 Spain Point-of-Care Testing Market by Prescription 185
15.3.4.3.4 Spain Point-of-Care Testing Market by End-User 186
15.3.4.4 Italy 186
15.3.4.4.1 Italy Point-of-Care Testing Market, By Product 187
15.3.4.4.2 Italy Point-of-Care Testing Market by Prescription 188
15.3.4.4.3 Italy Point-of-Care Testing Market by End-User 188
15.3.4.5 United Kingdom 189
15.3.4.5.1 United Kingdom Point-of-Care Testing Market, By Product 191
15.3.4.5.2 United Kingdom Point-of-Care Testing Market by Prescription 191
15.3.4.5.3 United Kingdom Point-of-Care Testing Market by End-User 192
15.3.4.6 Rest of Europe 192
15.3.4.6.1 Rest of the Europe Point-of-Care Testing Market, By Product 194
15.3.4.6.2 Rest of the Europe Point-of-Care Testing Market by Prescription 194
15.3.4.6.3 Rest of the Europe Point-of-Care Testing Market by End-User 195
15.4 Asia-Pacific POCT Market Insight 195
15.4.1 Asia-Pacific Point-of-Care Testing Market, By Product 196
15.4.2 Asia-Pacific Point-of-Care Testing Market by Prescription 197
15.4.3 Asia-Pacific Point-of-Care Testing Market by End-User 197
15.4.4 Asia-Pacific POCT Market by Country 198
15.4.4.1 China 198
15.4.4.1.1 Facts on Chinese Elderly Population 199
15.4.4.1.2 China Point-of-Care Testing Market, By Product 200
15.4.4.1.3 China Point-of-Care Testing Market by Prescription 200
15.4.4.1.4 China Point-of-Care Testing Market by End-User 201
15.4.4.2 India 201
15.4.4.2.1 India Point-of-Care Testing Market, By Product 203
15.4.4.2.2 India Point-of-Care Testing Market by Prescription 203
15.4.4.2.3 India Point-of-Care Testing Market by End-User 204
15.4.4.3 Japan 204
15.4.4.3.1 Japan Point-of-Care Testing Market, By Product 206
15.4.4.3.2 Japan Point-of-Care Testing Market by Prescription 207
15.4.4.3.3 Japan Point-of-Care Testing Market by End-User 207
15.4.4.4 Australia 208
15.4.4.4.1 Australia Point-of-Care Testing Market, By Product 210
15.4.4.4.2 Australia Point-of-Care Testing Market by Prescription 210
15.4.4.4.3 Australia Point-of-Care Testing Market by End-User 211
15.4.4.5 Rest of Asia-Pacific 211
15.4.4.5.1 Health Expenditure 212
15.4.4.5.2 Public Hospital Funding - District Health Boards 212
15.4.4.5.3 Mental Health 212
15.4.4.5.4 Disability Support Services 212
15.4.4.5.5 Reduction in costs of visiting GP 212
15.4.4.5.6 Rest of APAC Point-of-Care Testing Market, By Product 213
15.4.4.5.7 Rest of APAC Point-of-Care Testing Market by Prescription 214
15.4.4.5.8 Rest of APAC Point-of-Care Testing Market by End-User 214
15.5 Rest of World Market Insight 215
15.5.1 Rest of World Point-of-Care Testing Market, By Product 217
15.5.2 Rest of the world Point-of-Care Testing Market by Prescription 217
15.5.3 Rest of the world Point-of-Care Testing Market by End-User 218
16. COMPETITIVE SCENARIO 219
16.1 Porter's Five forces analysis 219
16.1.1 Bargaining Power of Suppliers 220
16.1.2 Bargaining Power of Buyers 220
16.1.3 Threat of New Entrants 221
16.1.4 Threat of Substitutes 222
16.1.5 Industry Rivalry 222
16.2 Market Share Analysis, by Company 223
16.2.1 Global Point-of-Care Testing Market Share Analysis, by Company 2018 223
17. TOP COMPANY PROFILES 225
17.1 Abbott Laboratories 225
17.1.1 Key Facts 225
17.1.2 Business Description 225
17.1.3 Key Product/Services Offerings 226
17.1.4 Growth Strategy 226
17.1.5 SWOT Analysis 227
17.1.6 Key Financials 228
17.1.6.1 Revenue Split 229
17.1.7 Recent Developments 229
17.1.7.1 Product Launches 229
17.1.7.2 Partnership 231
17.1.7.3 Merger and Acquisition 232
17.2 Becton, Dickinson and Company 233
17.2.1 Key Facts 233
17.2.2 Business Description 233
17.2.3 Becton Dickinson, and Company, Key Product/Services Offerings 233
17.2.4 Growth Strategy 234
17.2.5 SWOT Analysis 235
17.2.6 Key Financials 236
17.2.6.1 Revenue Split 237
17.2.7 Recent Developments 237
17.2.7.1 Product Launches 237
17.2.7.2 Business Expansions and Investments 238
17.2.7.3 Merger & Acquisition 238
17.3 Biomerieux SA 239
17.3.1 Key Facts 239
17.3.2 Business Description 239
17.3.3 Key Product/Services Offerings 240
17.3.4 Growth Strategy 240
17.3.5 SWOT Analysis 241
17.3.6 Key Financials 242
17.3.6.1 Revenue Split 243
17.3.7 Recent Developments 243
17.3.7.1 Product Launches 243
17.3.7.2 Partnerships 244
17.3.7.3 Mergers and Acquisitions 244
17.4 Bio-Rad Laboratories, Inc. 246
17.4.1 Key Facts 246
17.4.2 Business Description 246
17.4.3 Key Product/Services Offerings 247
17.4.4 Growth Strategy 248
17.4.5 SWOT Analysis 249
17.4.6 Key Financials 250
17.4.6.1 Revenue Split 251
17.4.7 Recent Developments 251
17.4.7.1 Product Launches 251
17.4.7.2 Mergers and Acquisition 252
17.5 Danaher Corporation 253
17.5.1 Key Facts 253
17.5.2 Business Description 253
17.5.3 Key Product/Services Offerings 253
17.5.4 Growth Strategy 254
17.5.5 SWOT Analysis 255
17.5.6 Key Financials 256
17.5.6.1 Revenue Split 257
17.5.7 Recent Developments 257
17.5.7.1 Merger and Acquisitions 257
17.6 Johnson & Johnson 258
17.6.1 Key Facts 258
17.6.2 Business Description 258
17.6.3 Key Product/Services Offerings 259
17.6.4 Growth Strategy 259
17.6.5 SWOT Analysis 260
17.6.6 Key Financials 261
17.6.6.1 Revenue Split 262
17.7 Roche Holding AG 263
17.7.1 Key Facts 263
17.7.2 Business Description 263
17.7.3 Key Product/Services Offerings 264
17.7.4 Growth Strategy 264
17.7.5 SWOT Analysis 265
17.7.6 Key Financials 266
17.7.6.1 Revenue Split 267
17.7.7 Recent Developments 267
17.7.7.1 Product Launches 267
17.7.7.2 Partnership 268
17.7.7.3 Mergers and Acquisitions 269
17.8 Siemens Healthineers AG 270
17.8.1 Key Facts 270
17.8.2 Business Description 270
17.8.3 Key Product/Services Offerings 271
17.8.4 Growth Strategy 271
17.8.5 SWOT Analysis 272
17.8.6 Key Financials 273
17.8.6.1 Revenue Split 274
17.8.7 Recent Developments 274
17.8.7.1 Product Launches 274
17.8.7.2 Partnerships 275
17.8.7.3 Business Expansion and Investment 275
17.8.7.4 Merger and Acquisition 275
17.9 Thermo Fisher Scientific 277
17.9.1 Key Facts 277
17.9.2 Business Description 277
17.9.3 Key Product/Services Offerings 278
17.9.4 Growth Strategy 280
17.9.5 SWOT Analysis 280
17.9.6 Key Financials 281
17.9.6.1 Revenue Split 282
17.9.7 Recent Developments 282
17.9.7.1 Product Launches 282
17.9.7.2 Partnerships 283
17.9.7.3 Business Expansion and Investments 283
17.9.7.4 Merger and Acquisition 284
17.10 Sysmex Corporation 285
17.10.1 Key Facts 285
17.10.2 Business Description 285
17.10.3 Key Product/Services Offerings 285
17.10.4 Growth Strategy 286
17.10.5 SWOT Analysis 287
17.10.6 Key Financials 288
17.10.6.1 Revenue Split 289
17.10.7 Recent Developments 289
17.10.7.1 Product Launches 289
17.10.7.2 Partnership 290
17.10.7.3 Business Expansion & Investments 291
17.10.7.4 Merger and Acquisition 291
List of Figure
FIG. 1 Scope of the Global Point-of-Care Testing Market Study 22
FIG. 2 Research Methodology for the Global Point-of-Care Testing (POCT) Market Study 23
FIG. 3 Assessment Categories to Capture the Full Spectrum of Value 29
FIG. 4 Key Diagnostic Stakeholder Groups 30
FIG. 5 A Schematic: Approach for Effective Value Assessment 32
FIG. 6 Challenges Facing by Diagnostics Providers 40
FIG. 7 Ways to Win Diagnostics Value Game 41
FIG. 8 Ways to Survive in the Value Game 42
FIG. 9 Consequences of Early vs Late Diagnostic Measures with Regard to Life Expectancy and Associated Cost 46
FIG. 10 Holistic disease management in the diagnosis of cervical cancer and its associated risk factor of HPV infection 47
FIG. 11 How interventions affect the current use of in vitro diagnostics 52
FIG. 12 Integrated Supply Chain Operations 68
FIG. 13 Key Risk categories for Supply Chain 69
FIG. 14 Capabilities to Support Risk Mitigation 70
FIG. 15 Global Point-of-Care Testing Market Size by Value, 2018-2025 73
FIG. 16 Comparison of Convectional Testing Procedure and POCT 76
FIG. 17 Cost Benefits Associated with POCT Adoption 76
FIG. 18 New Approaches to Shaping Care-iSTAT Process 77
FIG. 19 Points of Entry in the Diagnostics Supply Chain 80
FIG. 20 Number of Labs in the United States 81
FIG. 21 Recommendation for Improving the link between clinical needs and the development of new tests by industry 85
FIG. 22 Framework for Diagnostics Tests 87
FIG. 23 Principal Uses of Diagnostics Across the Health Care Continuum from Earliest Stages of Disease to Health Outcomes 88
FIG. 24 Timeline of key events related to IVDs and Laboratory-Developed Tests 97
FIG. 25 10 Common Chronic Condition for Adults over 65+ Years, 2017 100
FIG. 26 Prevalence of Chronic Disease in the US 100
FIG. 27 Global Leading Causes of Disability-Adjusted Life Year (DALY) per 100,000 population, 2000 and 2016 101
FIG. 28 Global Population over 60 years and above (in Billion) 102
FIG. 29 Global population by broad age group, in 2017, 2030 and 2050 104
FIG. 30 Artificial Intelligence and In Vitro Diagnostics: Advancing Patient Care 105
FIG. 31 Indian Healthcare Sector USD 80 Billion 106
FIG. 32 Critical Variables in POCT 108
FIG. 33 Companion Diagnostics Market: Most Common Disease Areas, North America 111
FIG. 34 Companion Diagnostics Market: Most common disease areas, Europe 111
FIG. 35 Top Five Factors that Influence IVD Companies' Business Models 114
FIG. 36 Digital Health Step Process Globally 115
FIG. 37 Global deaths per 100,000; in 2000 and 2017 116
FIG. 38 Facts regarding Chronic Diseases 117
FIG. 39 Projection of Deaths by Chronic diseases in 2020, (%) 117
FIG. 40 Supply Chain Management Framework for Improving Access to POC Diagnostics 119
FIG. 41 Impact of Early Supplier Involvement 121
FIG. 42 In-Vitro diagnostics Value Chain 131
FIG. 43 Applications of POCT 132
FIG. 44 Global Point-of-Care Testing Market, By Product 2018-2025 (%) 133
FIG. 45 Current & Projected Number of Diabetics Globally (2017 and 2045) 134
FIG. 46 Glucose Monitoring Market by Region, 2018-2025 (USD Million) 134
FIG. 47 Infertility and Related Facts 135
FIG. 48 Pregnancy and Fertility Testing Products by Region, 2018-2025 (USD Million) 136
FIG. 49 People Living with HIV by region, 2018 (in Million) 137
FIG. 50 Infectious Disease Testing Products Market by Region, 2018-2025 (USD Million) 138
FIG. 51 Comparison of CVD Mortality in High-Income Countries and Middle-Income Countries, 2017 138
FIG. 52 Cardiac Marker Market by Region, 2018-2025 (USD Million) 139
FIG. 53 Coagulation Testing Market by Region, 2018-2025 (USD Million) 140
FIG. 54 Cancer Burden and Mortality, 2018 (%) 141
FIG. 55 Other Global POCT Products Market by Region, 2018-2025 (USD Million) 141
FIG. 56 Global POCT Market Share, by Prescription, 2018 & 2025 (%) 142
FIG. 57 Global Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 142
FIG. 58 Near the Patient (NPT) Prescription Market by Region, 2018-2025 (USD Million) 143
FIG. 59 Over the Counter/Patient Self-Testing (OTC/PST) Prescription Market by Region, 2018-2025 (USD Million) 144
FIG. 60 Pyramid of Testing 146
FIG. 61 Global Point-of-Care Testing Market Share, by End User, 2018 & 2025 (%) 146
FIG. 62 Global Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 147
FIG. 63 POCT Connectivity Progression 148
FIG. 64 Hospitals End-user Market by Region, 2018-2025 (USD Million) 149
FIG. 65 Types of Laboratories, United States, 2017 150
FIG. 66 Clinics & Labs End-user Market by Region, 2018-2025 (USD Million) 151
FIG. 67 OraSure OraQuick In-Home HIV Test Kit 154
FIG. 68 Diabetes' iBGStar Blood Glucose Meter 154
FIG. 69 Home Setting End-User Market by Region, 2018-2025 (USD Million) 155
FIG. 70 Other End-Users Market by Region, 2018-2025 (USD Million) 156
FIG. 71 World Population Pyramid Transition, 1950-2100 (Billion) 157
FIG. 72 Number of Persons aged 60 years or older (Million) 158
FIG. 73 Global population by broad age group, in 1980, 2017, 2030 and 2050 (in billion) 159
FIG. 74 Global Point-of-Care Testing Market Share by Region 2018-2025 (%) 159
FIG. 75 Global Point-of-Care Testing Market by Region, 2018-2025 (USD Million) 160
FIG. 76 North America Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 161
FIG. 77 North America Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 162
FIG. 78 North America Point-of-Care Testing Market by Country, 2018-2025 (USD Million) 162
FIG. 79 Leading Causes of Death in the United States, per 100,000 Population (2016 & 2017) 163
FIG. 80 US Health Spending by Type of Service or Product, 2017 165
FIG. 81 United States Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 166
FIG. 82 United States Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 167
FIG. 83 Drivers Escalating the Growth of IVD Market in Canada 168
FIG. 84 Prevalence of Chronic Diseases Among Canadian Adults, 2019 168
FIG. 85 Canada Health Spending by Sources of Funds, 2017 169
FIG. 86 Canadian Hospital Spending by Type and Function, 2018 (%) 170
FIG. 87 Canada Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 171
FIG. 88 Canada Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 171
FIG. 89 Rest of NA Population ages 65 and above, by Country (% of total), 2018 172
FIG. 90 Proportional Mortality in 2017 173
FIG. 91 Rest of North America Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 174
FIG. 92 Rest of North America Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 174
FIG. 93 Number of Death Caused by Diseases of Circulatory System in Europe, by Country (2015) 175
FIG. 94 Europe Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 176
FIG. 95 Europe Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 177
FIG. 96 Europe Point-of-Care Testing Market by Country, 2018-2025 (USD Million) 177
FIG. 97 Proportional mortality in Germany, by percent (USD Million) 178
FIG. 98 Germany Health Spending 179
FIG. 99 Germany Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 180
FIG. 100 Germany Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 180
FIG. 101 Proportional Mortality in France by Disease Type (%) 181
FIG. 102 France Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 182
FIG. 103 France Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 183
FIG. 104 Major Causes of Death in Spain 2018 by Percentage (%) 184
FIG. 105 Spain Government Health Expenditure, 2010-2018 184
FIG. 106 Spain Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 185
FIG. 107 Spain Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 186
FIG. 108 Causes of Death in Italy by Gender, (%) 2014 187
FIG. 109 Italy Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 188
FIG. 110 Italy Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 188
FIG. 111 Population of the UK Recorded Over 65 Years in 2015, 2025, 2035 & 2045 (%) 189
FIG. 112 Causes of Death in England in Males and Females in 2015, by Percentage (%) 190
FIG. 113 UK Government Health Expenditure, 2013-2017 190
FIG. 114 United Kingdom Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 191
FIG. 115 United Kingdom Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 192
FIG. 116 Rest of Europe % of the population over 65 years old by Country, 2017 193
FIG. 117 Health Expenditure Per Capita by Country, 2017 (or nearest year) 193
FIG. 118 Rest of the Europe Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 194
FIG. 119 Rest of the Europe Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 195
FIG. 120 Role of Laboratory Services in Asia Pacific Region 196
FIG. 121 Asia-Pacific Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 197
FIG. 122 Asia-Pacific Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 197
FIG. 123 Asia-Pacific Point-of-Care Testing Market by Country, 2018-2025 (USD Million) 198
FIG. 124 China Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 200
FIG. 125 China Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 201
FIG. 126 Regulatory assessment of an IVD's 202
FIG. 127 India Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 203
FIG. 128 India Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 204
FIG. 129 Japanese Population Comparison by Age Group, 2018 & Future (% of the total population) 205
FIG. 130 Japanese Current & Future Per Capita Healthcare Spending by Source of Fund 2016 and 2050 (USD ) 206
FIG. 131 Japan Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 207
FIG. 132 Japan Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 207
FIG. 133 The Proportion of the Australian Population Aged 65 and Over, 2017, 2027, 2037, 2047 and 2057 (%) 208
FIG. 134 Total Health Expenses, USD Million 209
FIG. 135 Australia Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 210
FIG. 136 Australia Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 211
FIG. 137 Causes of Death in South Korea, (%) 2016 213
FIG. 138 Rest of APAC Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 214
FIG. 139 Rest of APAC Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 214
FIG. 140 Age Structural Transition, MENA countries, 1950-2100 (%) 215
FIG. 141 Brazilian Healthcare Sector Map 216
FIG. 142 Current Health Expenditure (% of GDP)-Brazil 216
FIG. 143 Rest of the world Point-of-Care Testing Market by Prescription, 2018-25 (USD Mn) 217
FIG. 144 Rest of the world Point-of-Care Testing Market by End-User, 2018-2025 (USD Million) 218
FIG. 145 Point-of-Care Testing Market: Porter's Five Forces Analysis 219
FIG. 146 Global Point-of-Care Testing Market Share Analysis, by Company 2018 223
FIG. 147 Abbott laboratories Solutions for Diagnostics 226
FIG. 148 Abbott laboratories SWOT Analysis 227
FIG. 149 Key Financials of Abbott Laboratories 228
FIG. 150 Abbott Laboratories Revenue Split, 2018 229
FIG. 151 Becton, Dickinson and Company Q3 FY19 Financial Results 234
FIG. 152 Becton, Dickinson and Company SWOT Analysis 235
FIG. 153 Key Financials of Becton, Dickinson and Company 236
FIG. 154 Becton, Dickinson and Company Revenue Split, 2018 237
FIG. 155 Biomerieux SA, Vision 2020 Objectives and Results at End of 2018 241
FIG. 156 Biomerieux SA, SWOT Analysis 241
FIG. 157 Key Financials of Biomerieux SA 242
FIG. 158 Biomerieux SA, Revenue Split, 2018 (%) 243
FIG. 159 Bio-Rad Laboratories, Inc., Clinical Diagnostic Testing Products 248
FIG. 160 Bio-Rad Laboratories, Inc., SWOT Analysis 249
FIG. 161 Key Financials of Bio-Rad Laboratories, Inc. 250
FIG. 162 Bio-Rad Laboratories, Inc., Revenue Split, 2018 (%) 251
FIG. 163 Danaher Corporation, Science & Technology Portfolio 255
FIG. 164 Danaher Corporation SWOT Analysis 255
FIG. 165 Key Financials of Danaher Corporation 256
FIG. 166 Danaher Corporation Revenue Split by Segment, 2018 257
FIG. 167 Johnson & Johnson, Impact made 259
FIG. 168 Johnson & Johnson SWOT Analysis 260
FIG. 169 Key Financials of Johnson and Johnson 261
FIG. 170 Johnson & Johnson Revenue Split, 2017 262
FIG. 171 Roche Holding AG, Top-selling Diagnostics Product Portfolios in 2018 (USD Million) 264
FIG. 172 Roche Holding AG Strategy 265
FIG. 173 Roche Holding AG SWOT Analysis 265
FIG. 174 Key Financials of Roche Holding AG 266
FIG. 175 Roche Holding AG Revenue Split, 2018 267
FIG. 176 Siemens Healthineers AG, Value Creation 271
FIG. 177 Siemens Healthineers AG SWOT Analysis 272
FIG. 178 Key Financials of Siemens Healthineers AG 273
FIG. 179 Siemens Healthineers AG, Revenue Split, 2018 274
FIG. 180 Thermo Fisher Scientific, Products Segment 278
FIG. 181 Thermo Fisher Scientific, SWOT Analysis 280
FIG. 182 Key Financials of Thermo Fisher Scientific 281
FIG. 183 Thermo Fisher Scientific, Revenue Split, 2018 (%) 282
FIG. 184 Sysmex Corporation, Promoting R&D Activities through Open Innovation 286
FIG. 185 Sysmex Corporation, SWOT Analysis 287
FIG. 186 Key Financials of Sysmex Corporation 288
FIG. 187 Sysmex Corporation, Revenue Split, 2018 (%) 289
List of Table
TABLE 1 Principles for Effective Value Assessments 27
TABLE 2 Considerations in Demonstrating Value by Diagnostic Test Type 33
TABLE 3 Value Driver: Clinical Impact 34
TABLE 4 Value Driver: Non-Clinical Patient Impact 36
TABLE 5 Value Driver: Care Delivery Revenue and Cost Impact 37
TABLE 6 Value Driver: Public/Population Impact 39
TABLE 7 Overview of Selected Compounds and their Companion Diagnostics, beyond the field of Oncology 49
TABLE 8 Application of the outcome measures hierarchical tier system described by Porter to reinforcement interventions proposed as solutions to the shifting the burden archetype in the in-vitro diagnostics arena 50
TABLE 9 The risk Identified by POCT Manufacturers and Solutions 67
TABLE 10 Examples of Commonly Used POCT 75
TABLE 11 Categories and Examples of Diagnostic Products 78
TABLE 12 Rapidly Expanding Areas of Scientific Inquiry 91
TABLE 13 Number and distribution of persons aged 60 years or over by region, in 2017 and 2050 104
TABLE 14 Classification system for IVD's medical devices based on risk 107
TABLE 15 Oncology CDx Market: Selected Tests Resulting from Partnerships, U.S., 2017 112
TABLE 16 POCT Market Regulatory Analysis, Selected Regions 113
TABLE 17 Recent Product Launches 121
TABLE 18 Recent Partnership 126
TABLE 19 Recent Expansion Expansions & Investment 128
TABLE 20 Mergers and Acquisitions 129
TABLE 21 Global Point-of-Care Testing Market, By Product, 2018-2025 (USD Million) 133
TABLE 22 Clinical Laboratory Improvement Amendments (CLIA)-waived tests for Infectious Diseases 137
TABLE 23 Percentage of time in the target range 144
TABLE 24 General POCT for Primary Health Care 151
TABLE 25 Countries with Shift in Average Life Expectancies in 2030 157
TABLE 26 Ten countries with the largest share of persons aged 60 years 2017 & 2025 158
TABLE 27 North America Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 161
TABLE 28 United States Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 166
TABLE 29 Canada Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 170
TABLE 30 Rest of North America Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 173
TABLE 31 Europe Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 176
TABLE 32 Germany Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 179
TABLE 33 France Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 182
TABLE 34 Spain Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 185
TABLE 35 Italy Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 187
TABLE 36 United Kingdom Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 191
TABLE 37 Rest of the Europe Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 194
TABLE 38 Asia-Pacific Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 196
TABLE 39 China Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 200
TABLE 40 India Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 203
TABLE 41 Japan Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 206
TABLE 42 Australia, Total Health Expenses, USD Million 210
TABLE 43 Australia Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 210
TABLE 44 Rest of APAC Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 213
TABLE 45 Rest of World Point-of-Care Testing Market by Product, 2018-2025 (USD Million) 217
TABLE 46 Abbott Laboratories Key Facts 225
TABLE 47 Product segmentation of Abbott Laboratories 226
TABLE 48 Abbott Laboratories Growth Strategy 226
TABLE 49 Abbott Laboratories, Inc. Product Launches 229
TABLE 50 Abbott Laboratories, Inc. Partnership 231
TABLE 51 Abbott Laboratories, Inc. Merger and Acquisition 232
TABLE 52 Becton, Dickinson and Company Key Facts 233
TABLE 53 Becton, Dickinson and Company Key Product/ Services Offerings 233
TABLE 54 Becton, Dickinson and Company Growth Strategy 234
TABLE 55 Becton, Dickinson and Company Product Launches 237
TABLE 56 Becton, Dickinson and Company Business Expansions and Investments 238
TABLE 57 Becton, Dickinson and Company Merger & Acquisition 238
TABLE 58 Biomerieux SA Key Facts 239
TABLE 59 Product segmentation of Biomerieux SA 240
TABLE 60 Biomerieux SA Growth Strategy 240
TABLE 61 Biomerieux SA Product Launches 243
TABLE 62 Biomerieux SA Partnerships 244
TABLE 63 Biomerieux SA Mergers and Acquisitions 244
TABLE 64 Bio-Rad Laboratories, Inc. Key Facts 246
TABLE 65 Product Segmentation of Bio-Rad Laboratories, Inc. 247
TABLE 66 Bio-Rad Laboratories, Inc. Growth Strategy 248
TABLE 67 Bio-Rad Laboratories, Inc. Product Launches 251
TABLE 68 Bio-Rad Laboratories, Inc. Merger and Acquisition 252
TABLE 69 Danaher Corporation Key Facts 253
TABLE 70 Product Segmentation of Danaher Corporation 253
TABLE 71 Danaher Corporation Growth Strategy 254
TABLE 72 Danaher Corporation Merger and Acquisitions 257
TABLE 73 Johnson & Johnson Key Facts 258
TABLE 74 Product segmentation of Johnson & Johnson 259
TABLE 75 Johnson & Johnson Growth Strategy 259
TABLE 76 Roche Holding AG Key Facts 263
TABLE 77 Product Segmentation of Roche Holding AG 264
TABLE 78 Roche Holding AG Growth Strategy 264
TABLE 79 Roche Holding AG Product Launches 267
TABLE 80 Roche Holding AG Partnership 268
TABLE 81 Roche Holding AG Mergers and Acquisitions 269
TABLE 82 Siemens Healthineers AG Key Facts 270
TABLE 83 Product Segmentation of Siemens Healthineers AG 271
TABLE 84 Siemens Healthineers AG Growth Strategy 271
TABLE 85 Siemens Healthineers AG Product Launches 274
TABLE 86 Siemens Healthineers AG Partnerships 275
TABLE 87 Siemens Healthineers Business Expansion and Investment 275
TABLE 88 Siemens Healthineers Merger and Acquisition 275
TABLE 89 Thermo Fisher Scientific Key Facts 277
TABLE 90 Product segmentation of Thermo Fisher Scientific 278
TABLE 91 Thermo Fisher Scientific Growth Strategy 280
TABLE 92 Thermo Fisher Scientific Product Launches 282
TABLE 93 Thermo Fisher Scientific Partnerships 283
TABLE 94 Thermo Fisher Scientific Business Expansion and Investments 283
TABLE 95 Thermo Fisher Scientific Merger and Acquisition 284
TABLE 96 Sysmex Corporation Key Facts 285
TABLE 97 Product segmentation of Sysmex Corporation 285
TABLE 98 Sysmex Corporation Growth Strategy 286
TABLE 99 Sysmex Corporation Product Launches 289
TABLE 100 Sysmex Corporation Partnership 290
TABLE 101 Sysmex Corporation Business Expansion & Investments 291
TABLE 102 Sysmex Corporation Merger and Acquisition 291
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